Diphenhydramine 50mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Diphenhydramine hydrochloride

Dostupné z:

Ennogen Healthcare Ltd

ATC kód:

R06AA02

INN (Medzinárodný Name):

Diphenhydramine hydrochloride

Dávkovanie:

50mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 03040100

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
Diphenhydramine 50mg Tablets
Diphenhydramine Hydrochloride
READ ALL OF THIS LEAFLET BEFORE YOU START TAKING THIS MEDICINE BECAUSE
IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has
told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
•
You must talk to a doctor if you do not feel better, or if you feel
worse after 7 days.
WHAT IS IN THIS LEAFLET
1.
What Diphenhydramine 50mg Tablets are and what are they used for
2.
What you need to know before you take Diphenhydramine 50mg Tablets
3.
How to take Diphenhydramine 50mg Tablets
4.
Possible side effects
5.
How to store Diphenhydramine 50mg Tablets
6.
Contents of the pack and other information
1.
WHAT DIPHENHYDRAMINE 50MG TABLETS ARE AND WHAT ARE THEY USED FOR
THESE TABLETS ARE USED TO RELIEVE TEMPORARY SLEEPING DIFFICULTIES.
The active ingredient is diphenhydramine hydrochloride, an
antihistamine that causes sleepiness
or drowsiness. Temporary difficulties in getting a good night's sleep
can be caused by various
problems such as stress, jet lag or personal problems such as
bereavement. In sleep problems of
this type, Diphenhydramine 50mg tablets have been shown to help people
to fall asleep faster
and to have a longer and deeper sleep. You must talk to a doctor after
7 days if you do not feel
better, or if you feel worse.
You should not drive or operate machinery for at least 8 hours after
taking the tablet.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIPHENHYDRAMINE 50MG TABLETS
DO NOT TAKE THESE TABLETS:
•
IF YOU HAVE EVER HAD AN ALLERGIC REACTION
to diphenhydramine hydrochloride or to any of the
other ingredients (listed in Section 6)
•
if you have an
OBSTRUCTION IN YOUR STOMACH OR GUT
(for example, because of

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diphenhydramine 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg Diphenhydramine Hydrochloride (equivalent to
43.8mg
Diphenhydramine base)
Excipients with known effect:168.75mg lactose. For the full list of
excipients, see
section 6.1.
3
PHARMACEUTICAL FORM
A white to off white, 15mm in length, oblong capsule-shaped tablet,
embossed with
“N50” logo on both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Diphenhydramine 50mg Tablets are indicated as a symptomatic aid to the
relief of
temporary sleep disturbance in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
One tablet to be taken 20 minutes before going to bed, or as directed
by a physician.
Do not exceed the maximum dose of one tablet in 24 hours.
_Elderly_
The product should only be given to the elderly if the benefits for
the patient
outweigh the potential risks (see section 4.4).
_ _
_Renal and Hepatic Impairment_
In patients with moderate to severe renal or hepatic impairment, a
lower dose might
be required (see section 4.4).
_Paediatric population_
Diphenhydramine 50mg Tablets should not be used in children under 18
years.
Method of administration
Oral administration only.
Do not exceed the stated dose or frequency of dosing. The product
should not be
taken for more than 7 days without consulting a doctor.
4.3
CONTRAINDICATIONS
Diphenhydramine 50mg Tablets are contraindicated in patients who are
hypersensitive to the active substance (diphenhydramine hydrochloride)
or to any of
the excipients listed in section 6.1.
Diphenhydramine 50mg Tablets are also contraindicated in patients with
the
following conditions:
•
Stenosing peptic ulcer
•
Pyloroduodenal obstruction
•
Phaeochromocytoma
•
Known acquired or congenital QT interval prolongation
•
Known risk factors for QT interval prolongation including a known
cardiovascular disease, significant electrolytes imbalance
(hypokalaemia,
hypomagnesaemia), family history of